Skip to content

ACN - 101321555 | ABN - 39101321555

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

AHRECS icon
  • Home
  • About Us
    • Consultants
    • Services
  • Previous Projects
  • Blog
  • Resources
  • Feeds
  • Contact Us
  • More
    • Request a Quote
    • Susbcribe to REM
    • Subscribe to VIP
Menu
  • Home
  • About Us
    • Consultants
    • Services
  • Previous Projects
  • Blog
  • Resources
  • Feeds
  • Contact Us
  • More
    • Request a Quote
    • Susbcribe to REM
    • Subscribe to VIP
Exclude terms...
Aboriginal and Torres Strait Islander
AHRECS
Analysis
Animal ethics
Animal Ethics Committee
Animal handling
Animal housing
Animal Research Ethics
Animal Welfare
ANZCCART
Artificial Intelligence
Arts
Australia
Authorship
Belief
Beneficence
Big data
Big data
Biobank
Bioethics
Biomedical
Biospecimens
Breaches
Cartoon/Funny
Case studies
Clinical trial
Collaborative research
Conflicts of interest
Consent
Controversy/Scandal
Controversy/Scandal
Creative
Culture
Data management
Database
Dual-use
Essential Reading
Ethical review
Ethnography
Euthanasia
Evaluative practice/quality assurance
Even though i
First People
Fraud
Gender
Genetics
Get off Gary Play man of the dog
Good practice
Guidance
Honesty
HREC
Human research ethics
Humanities
Institutional responsibilities
International
Journal
Justice
Links
Media
Medical research
Merit and integrity
Methodology
Monitoring
New Zealand
News
Online research
Peer review
Performance
Primary materials
Principles
Privacy
Protection for participants
Psychology
Publication ethics
Questionable Publishers
Research ethics committees
Research integrity
Research Misconduct
Research results
Researcher responsibilities
Resources
Respect for persons
Sample paperwork
sd
se
Serious Adverse Event
Social Science
SoTL
Standards
Supervision
Training
Vulnerability
x
Young people
Exclude news

Sort by

Animal Ethics Biosafety Human Research Ethics Research Integrity

Research Ethics Monthly | ISSN 2206-2483

Lost time may never be found again but is it time to talk about the duration of ethics approvals?

Posted by saviorteam
in Human Research Ethics
on March 2, 2020
0 Comments
Keywords Australia,Ethical review,Good practice,Governance,HREC,Institutional Responsibilities,Research Ethics Committees,Research Integrity,Researcher responsibilities,Training
A detective peering through a magnifying glass

“To everything there is a season, and a time to every purpose” a time to report on ethical conduct, a time to renew an approval, or a time to face misconduct proceedings.

Dr Gary Allen

What is the length of ethics approvals that your HREC grants?  In this article, I will discuss this question and some of the reasons for choosing approval periods.

A related question is, under what circumstances should an ethics approval be withdrawn?  Can/should research ethics review bodies withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report?

Australia is unlike the US where the conventional interpretation of the Common Rule is that ethics approvals are of one year.  Accordingly, US researchers must provide annual ethical conduct reports to maintain ethics approval and avoid needing to make a fresh application.

In Australia, the duration of approval is not specified by the National Statement and the only clear Australia-wide external requirement to provide reports in a certain time is paragraph 5.5.5 of the National Statement which provides that researchers should report to ethics review bodies at least annually.  As a result, approval duration is likely to be dictated by institutional policy and some have adopted maximum duration periods.  A short (e.g. 12 months) approval period and renewal requirement is one lever committees can use to compel researcher compliance to provide evidence that the needs for approval periods are being met.

There are, I suggest, four such needs that are served by a choice of duration of an ethics approval, namely:

  • Compelling a report from a researcher and allowing a review body to confirm that –
    1. a project is being conducted as per the approval, and
    2. the welfare and interests of participants are still being adequately provided for.
  • Providing an opportunity to reflect on any changes to national standards or institutional policies or pertinent cases that warrant a rethink of approvals.

Researchers can typically seek a long duration ethics approval because:

  • The design calls for repeated data collection across an extended period, such as a longitudinal ethnographic study;
  • The work is a component of a program of work focussed on a cure for a chronic condition; or
  • The work intends to compile an archive of biospecimens, data, document samples, audio-visual material or other items of historical/cultural significance.

The maximum duration of a research ethics approval would also appear to be connected to how long an HREC has operated and the amount of work the committee is undertaking. In Australia, institutional decisions on the matter can also be associated with changes in national ethics review requirements that occurred in 1999, 2007 and 2018 (and beyond).

Like other aspects of human research ethics practice in Australia, the approach to duration has reflected practice in the United States.  While Australia does not have the same kind of regulatory framework as the US where failing to maintain ethics approval can have consequences for institutions, the use of single year approvals is probably used as a way to promote adherence to the institution’s ethical conduct reporting requirement.

While understandable, such short-term approvals can punish conscientious researchers because of an institutional response to recalcitrant researchers.

However, early in a research ethics committee’s operation, it is not uncommon for it to grant approvals with durations of between one and three years.

This can reflect the committee’s confidence:

  1. in its role and decisions;
  2. and trust that researchers understand their responsibilities and will abide within the scope of the ethics approval; and
  3. that projects will progress as per applications or researchers will contact the institution’s research office if the unexpected occurs.

A low workload of a committee can serve as an incentive for short duration approvals and longer duration/longitudinal work is chunked out into two or more applications. Increasing the number of approvals may not allow the committee and research team to develop expertise before the committee commits to an extended period of research. Alternatively, a committee might be tempted to inflate its number of approvals artificially to attract either resources or credibility.

Conversely, when a research ethics committee is very busy, there may be more incentive to grant longer approvals to minimise the number of times the committee needs to review renewals of long duration projects.

Given, the National Statement (2007 updated 2018) is currently silent on the issue of the duration of ethics approvals, it might appear the Australian national framework should not impact on approvals. However, there is both a predictable impact and a real reason to rethink our current approach to the duration of approvals.

At this stage an update to Section 4 of the National Statement might be released in the next six months and an update to Section 5 will move out of the planning stage shortly.

Some institutions and committees tie the duration of ethics approvals and forced renewal around the timeframe during which the national arrangements might change (and perhaps inter alia institutional policy).  In Australia this might equate to around a five year approval duration.

The changed approach to updates to the National Statement means that such a cycle might not be especially helpful.

Suggested change to duration and monitoring procedures

We recommend institutions and HRECs do the following:

  1. Adopt a policy setting that the conduct of human research without prior ethics approval may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and of the institution’s research integrity arrangements. This would be consistent with the Investigation good practice guide.
  2. Adopt a policy setting that any proposed change to a project must be submitted for prior review, otherwise the conduct of a project in a manner not in adherence to its ethics approval may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  3. Adopt the practice of reminding researchers of their responsibility –
    1. to consider and safeguard the welfare of research participants
    2. to remain reflective of whether the risks of a project are justified by its benefits
    3. to remain reflective of the degree to which the project addresses the core ethical principles of the National Statement
    4. notify the HREC of any changes with regard to 3a-c.
    5. Notify the HREC if any participant raises a concern about the ethical design or conduct of a project. Including notifying the HREC if any participants withdraw consent because of a concern about ethical matters.
  4. Adopt a policy that a researcher who fails to meet the responsibilities described at 3 may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  5. Adopt a policy that an ethics approval can be approved for the planned duration of a project.
  6. Adopt a policy that researchers must submit an ethical conduct report every 12 months during the currency of an ethics approval. Extended/repeated failure to do so may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  7. Adopt a practice of timed reminders to researchers to provide overdue ethical conduct reports, culminating in breach proceedings[1].
  8. Adopt a policy and practice that every five years a clearance is active the research office/HREC assess whether there are circumstances that require a new ethics review of a project.

In most cases, a new review should not be required, but a standardised, clear checklist should be used to determine whether a new review is required. Subscribers to https://www.ahrecs.vip or https://www.patreon.com/ahrecs will find a suggested checklist for conducting such a check.

On this basis, I suggest research ethics review bodies/research offices can and should withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report.  This however must be based upon documented policy and procedure.  It must also be foreshadowed in ethics approval notifications, report reminders and resource material.

[1] The approach here might be constrained by the research management system the institution is using.  This includes usefully tracking correspondence between the researchers and the research office.

This post may be cited as:
Allen, G. (3 March 2020) Lost time may never be found again but is it time to talk about the duration of ethics approvals?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/lost-time-may-never-be-found-again-but-is-it-time-to-talk-about-the-duration-of-ethics-approvals

Related reading

No related Posts found

Leave a Comment Cancel Reply

Your email address will not be published. Required fields are marked *

About the Corresponding Author

Admin

Sp-user Link
Facebook-f Twitter Linkedin-in Sp-mail User

About the blog

The senior consultants started AHRECS in 2007. We were looking for a way of responding to requests for advice on research ethics and integrity from the government, health and education sectors read more…

Comment rules

We decided to include comment functionality in the Blog because we want to encourage the Research Integrity and Human Research Ethics communities to contribute to public discourse about resourcing and improving practice. read more…

Related Links

Complaints against Research Ethics Monthly

Request a Takedown

Submission Guidelines

About the Research Ethics Monthly

About subscribing to the Research Ethics Monthly

A smiling group of multi-racial researchers

Random selected image from the AHRECS library. These were all purchased from iStockPhoto. These are images we use in our workshops and Dr Allen used in the GUREM.

Research Ethics Monthly Receive copies of the Research Ethics Monthly directly
by email. We will never spam you.

  • Enter the answer as a word
  • Hidden
    This field is hidden and only used for import to Mailchimp
  • This field is for validation purposes and should be left unchanged.
  • Home
  • Services
  • About Us
  • Contact Us
  • Home
  • Services
  • About Us
  • Contact Us
  • Company
  • Terms Of Use
  • Copyright
  • Privacy Policy
  • Company
  • Terms Of Use
  • Copyright
  • Privacy Policy
  • Site Map
  • Site Map

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Facebook-f Twitter Linkedin-in